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Mylabtwice Model 6200

by Esaote S.p.A.

510(k) K100931

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100931↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK100931 Date25 Jun 2010ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100931 decided 25 Jun 2010 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
IYN
FDA applicant
Esaote, S.p.A.
Device class
Class II
Regulation
21 CFR Part 892.1550
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mylabtwice Model 6200 is a portable ultrasound imaging system designed for diagnostic radiology applications. It provides real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and vascular systems for diagnostic purposes.

This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. It operates within standard MRI safety guidelines for non-MRI environments and requires proper maintenance and calibration as outlined in manufacturer instructions. Authorized for use in the United States under FDA 510(k) clearance (K100931) and compliant with the Medical Device Directive (MDD)

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

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